Halobetasol propionate, is in widespread use for the treatment of various dermatological conditions. Typically, halobetasol materials are used in cream or ointment based preparations, and one such product in wide commercial use is sold under the trade name “Ultravate® Cream” (halobetasol propionate 0.05% cream). Ultravate® Cream is generally regarded as a standard in the art. While, in many instances, physicians and/or patients prefer lotion-based preparations, it is generally believed that lotion-based preparations of corticosteroids are inferior in their therapeutic performance as compared to corresponding cream-based preparations.
As will be explained in detail hereinbelow, the present invention is directed to lotion-based preparations of halobetasol propionate and its salts, as well as other halobetasol esters and their salts, solvates, and the like (collectively “halobetasol materials”). Examples of halobetasol esters include, but are not limited to, acetate and butyrate esters. Halobetasol propionate 0.05% lotion of the present invention has high patient acceptability and demonstrates a clinical efficacy which is equal to, and in many instances superior to, that of cream-based halobetasol propionate 0.05% preparations. In addition, it has been found that the compositions of the present invention are stable and demonstrate very good long term storage stability. As will be further explained herein below, experimental data demonstrates that compositions of the present invention are very effective in reducing transepidermal water loss (TEWL) which is a highly desirable benefit in the management of dry and inflammatory skin conditions. Skin conductance studies have also demonstrated that the compositions of the present invention very rapidly penetrate outer skin layers ensuring optimal hydration. The compositions of the present invention comprise particular combinations of ingredients which interact synergistically to produce the enhanced results described above.